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Placebo tablets will be administered twice daily. The placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Females, if of child-bearing potential, must practice true abstinence or be competent to use adequate contraception and agree to maintain this throughout the study

Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law is/are able to read, understand, and provide written informed consent

Has one (or more) identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug

If currently taking an acetylcholinesterase inhibitor and/or memantine, the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study.

Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI

Resides in hospital or moderate to high dependency continuous care facility

History of swallowing difficulties

Pregnant or breastfeeding

Glucose-6-phosphate dehydrogenase deficiency

History of significant hematological abnormality or current acute or chronic clinically significant abnormality

Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator

Clinically significant cardiovascular disease or abnormal assessments

Preexisting or current signs or symptoms of respiratory failure

Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than bvFTD

Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years

Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients

Treatment currently or within 90 days before Baseline with any of the following medications (unless otherwise noted):

Tacrine

Amphetamine or dexamphetamine

Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)

Carbamazepine, primidone

Drugs for which there is a warning or precaution in the labeling about methemoglobinemia at approved doses

Current or prior participation in a clinical trial as follows:

Clinical trial of a product for cognition within 3 months of Screening (unless confirmed to have been randomized to placebo)

A clinical trial of a drug, biologic, device, or medical food in which the last dose/administration was received within 28 days prior to Baseline